About Us
At Capgemini Engineering Switzerland, we value excellence, diligence, responsibility, dynamism, and innovation. We offer a diverse workplace where you can grow professionally and personally. We are seeking an experienced CSV Engineer.
Job Description
* Assess and produce CSV packages on assigned projects, taking ownership of the work.
* Plan, coordinate, and execute computer system validation phases for production and QC Lab systems, including validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts.
* Prepare, review, and approve technical and GMP-related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation).
* Understand customer needs and define electronic records requirements for computerized systems, adhering to regulations and company standards.
* Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems.
* Contribute to ensuring that changes introduced in systems, procedures, processes, and formulas are managed, assessing all aspects of equipment/computerized systems commissioning and qualification.
Your Profile
* Bachelor's/Master's degree in technical or natural sciences.
* Minimum 4 years of experience with CSV.
* Minimum 3 years of experience within pharma or biotech companies.
* Familiarity with CSV requirements according to FDA 21CFR part 11/EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines.
* Experience defining strategy and validating computerized manufacturing equipment (CSV context).
* Excellent communication skills.
* Analytical thinking and problem-solving ability.
* Ability to work under minimal supervision, assess priorities, and work well under pressure in a fast-paced environment.
* Fluent in English.
Benefits
1. 30-70% remote work agreement with your manager and client needs (40% for cross-border due to tax regulations).
2. Ergonomically proven equipment options (monitor & chair) for home-office premises.
3. Support for trainings, formation upon agreement with the manager.
4. Gym subscription contribution.
5. Trust-based managerial culture.
6. Team rituals and get-togethers.